The prevalence of self-medication in breastfeeding mothers during the COVID-19 pandemic

Abstract Background Self-medication is an important health and social issue, especially for women due to critical periods such as pregnancy and lactation. Accordingly, this study aimed to investigate the use of nonprescribed medications by lactating mothers visiting health centers affiliated to Kerman University of Medical Sciences during the COVID-19 pandemic. Material and Methods This descriptive-analytical cross-sectional study was conducted in Kerman from October to December 2020. The research population included all lactating women who visited health centers affiliated to Kerman University of Medical Sciences to receive health services. The data in this study were collected using a checklist. Results A total of 228 mothers who met the inclusion criteria participated in the study. A total of 221 mothers (97.0%) received nonprescribed medications (377 drugs in total). Among 377 nonprescribed medications, 279 drugs (74.0%) could be used while breastfeeding. The three most commonly used nonprescribed medications were acetaminophen tablets (84 [22.3%]), gelofen compound (51 [13.5%]), and adult cold medications. The majority of the mothers, 153 (40.6%), chose nonprescribed medications based on pharmacy staff recommendations. The COVID-19 outbreak was the most common reason for using 246 (65.3%) nonprescribed drugs. There was a statistically significant relationship between the mothers’ education and the accuracy of their information about the side effects of nonprescribed medications use. Conclusion The prevalence of self-medication by lactating women during the COVID-19 pandemic was very high. A significant percentage of the mothers did not have correct information about the adverse effect of arbitrary use of nonprescribed drugs on their babies.


Material and methods
This descriptive-analytical cross-sectional study was conducted in Kerman from October to December 2020. This study was approved by the ethics committee of Kerman University of Medical Sciences under the number IR.KMU. REC.1399.363. Each participant read and signed an informed consent form before beginning the study. The research population included all the breastfeeding women who visited health centers (10 centers in total) affiliated to Kerman University of Medical Sciences to receive health services. Sampling was performed in all the centers. Mothers who were not residents of Kerman, mothers who exclusively used a formula to feed their infants, and those who were barred from breastfeeding their infants due to certain diseases were excluded from the study. A self-designed checklist was used to collect data. The checklist was designed based on expert opinions of six specialists in this regard. It contained two separate sections. The items in the first section assessed the participants' demographic characteristics (age of mothers and infants, route of birth delivery, mothers' education and jobs, and fathers' jobs and income per month). The first part of the second section evaluated the infant's diet, such as the use of formula or complementary food in addition to breast milk, and the daily breastfeeding patterns. Then, the participants answered a question in the checklist: 'Have you used any chemical or herbal medicines during breastfeeding without consulting your doctor?' A positive answer to this question confirmed the arbitrary use of drug(s) during lactation. The rest of the questions in the second part were completed only by the mothers who were taking medication arbitrarily during breastfeeding. These questions were about the sources of the drug information that convinced the participants to turn to the arbitrary use of drugs, the number of medications used by the mothers, duration of the nonprescribed medication use, time of the drug use during the 18 months after delivery (the first, second, and third six months), common indications for self-medication, the reasons for arbitrary use of the drugs, reading the drugs' information leaflets before using them, and their effects on the quality and quantity of milk. The mothers were also asked about the secretion of the drug into breast milk, whether the drug use during lactation was permissible or not, routine breastfeeding while taking nonprescribed medications, and the adverse effects of the drug use on the infants during breastfeeding. The accuracy of the data provided by the mothers about the secretion of the drug into breast milk, routine breastfeeding while taking the nonprescribed medications, and the adverse of drugs, patients' attitude toward health care providers, socioeconomic factors, long waiting times at the health facilities, medication expense, education level, age, monthly income, and people's satisfaction with and beliefs about medicines and diseases [4,5]. Moreover, women are more interested in the arbitrary use of drugs to treat problems such as painful menstruation, menopausal symptoms, mood disorders, and prevention of osteoporosis, as well as problems that occur during pregnancy and lactation [6]. Analgesics, laxatives, vitamins, antibiotics, and sedatives are the most commonly used postpartum drugs [7]. Medication use is common during breastfeeding. For instance, a study on pregnant and lactating women in the United States found that most women used at least one drug and an average of 3.3 drugs during breastfeeding [8].
Another study showed that the prevalence of arbitrary drug use during lactation in the Netherlands was approximately 65%. Besides, 61.2% of the mothers had poor awareness about the correct use of drugs [6]. However, most mothers are concerned about taking medication while breastfeeding and may use information about whether or not to take medications from different sources, including physicians, pharmacists, midwives, spouses, friends and neighbors, or media; they stop breastfeeding in some cases without the desire to do so as a result of incorrect advice from others [9]. Thus, breastfeeding women need correct advice on the use of medications during breastfeeding [10]. It should be noted that the use of drugs during breastfeeding by mothers without a physician's advice may affect breast milk, or the drug may reach the baby through milk [11]. On the other hand, since the last two years, as the world has been facing the COVID-19 pandemic, there has been a general misconception that the only source available to people to help them is self-care and self-medication [12]. Dissemination of fake news [13] and the existence of concerns and restrictions such as lockdowns and prohibitions on attending very crowded places such as doctors' offices have promoted the use of self-medication in various groups of society. Furthermore, pregnant and lactating women are much more concerned about the transmission of the COVID-19 disease and even death due to it. These concerns may increase the possibility of arbitrary drug use among women [14]. Considering these factors, the present study aimed to investigate the prevalence of arbitrary drug use and factors affecting it in lactating mothers visiting health centers affiliated to Kerman University of Medical Sciences during the COVID-19 pandemic and to determine the accuracy of the mothers' information about arbitrary drug use. effects of the drug use on the infants during breastfeeding were checked using the information available in the UptoDate Database (http://www.uptodate.com, accessed 2021), Neonatal Risk: Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk (Briggs,11 th Edition) [15], and drug information leaflets. Drug information leaflets were used for some drugs that were approved only by the Iran Food and Drug Administration. The information on some drugs was only in UptoDate Database or Briggs. The Anatomical Therapeutic Chemical (ATC) classification system [16] was also used in this study to classify the drugs used by the mothers. The sample size was estimated to be 96 persons using the following formula: N = z 2 × p (1-p) / d 2 . In this formula, z (with a 95% confidence interval), p and d were considered as 1.96, 0.5 and 0.1, respectively. According to the previous studies, the prevalence of nonprescribed medications used during lactation was 17% to 75% [8,17,18]. The Statistical Package for Social Science (SPSS) version 23 was used for all the analyses. Descriptive analysis was applied for all the variables. Chi-square and one-way analysis of variance were employed to compare qualitative and quantitative data, respectively. A p-value of less than 0.05 was considered statistically significant.

Results
A total of 228 mothers who met the inclusion criteria completed the checklist. Among them, 221 mothers used nonprescribed medications. The participants' mean age was 30.5 ± 5.7 years. Moreover, the mean age of the participants' children was 10.1 ± 5.2 months. The demographic characteristics of the participating mothers, infants' diets, and daily breastfeeding patterns are presented in Table 1. In addition, there was not any significant relation between the number of the breastfeeding sessions and the use of nonprescribed medications by mothers (P-value = 0.925). Among 221 mothers using nonprescribed medications, 115 (52.0%), 79 (35.8%), and 27 (12.2%) mothers breastfed their babies 5 to 10, more than 10, and less than 5 times per day, respectively. The data indicated that 221 participants (97.0%) received a total of 377 nonprescribed medications. Among all the 221 mothers, 120 (54.3%), 66 (30.0%), 24 (10.8%), 9 (4.1%), 1 (0.4%), and 1(0.4%) mother(s) used 1, 2, 3, 4, 5, and 6 nonprescribed medication(s), respectively. The three most commonly used nonprescribed medications were acetaminophen tablets (84 [ Table 2 shows the nonprescribed medications classification based on the Anatomical Therapeutic Chemical classification system. As shown in Table 2 Table 3 presents the source of the drug information for self-medication, time of the nonprescribed      Table 5. Some mothers chose more than one reason.  Table 7 shows the classification of nonprescribed medications (n = 377) during breastfeeding based on UptoDate Database, drug information leaflets, and Briggs.
Also, there was a statistically significant relationship between the participants' education and their correct information about the side effects of nonprescribed medications (P-value = 0.0001). The more educated mothers were, the more accurate their information was. However, the mothers' jobs (P-value = 0.214) and age (P-value = 0.760), and fathers' jobs (P-value = 0.742) and household income (P-value = 0.098) had no significant correlations with the mothers' correct information about the side effects of nonprescribed medications. Furthermore, the mothers' jobs (P-value = 0.019) were significantly associated with the correct approach to routine breastfeeding. However, the mothers' education (P-value = 0.533) and age (P-value = 0.355), and fathers' jobs (P-value = 0. 905) Limited human data -probably compatible 6 (1.6%) Breastfeeding is allowed only upon the physician's advice Breastfeeding is not recommended by the manufacturer 10 (2.7%) Limited human data -potential toxicity 2 (0.5%) and household income (P-value = 0.377) were not significantly associated with this approach. Moreover, the mothers' education (P-value = 0.0001) and age (P-value = 0.007), and fathers' jobs (P-value = 0.008) and household income (P-value = 0.001) had significant effects on the accuracy of the mothers' information about the secretion of the drug into breast milk, while the mothers' job (P-value = 0.372) had no significant effect on it.

Discussion
This study examined the use of nonprescribed medications by breastfeeding mothers visiting health centers affiliated to Kerman University of Medical Sciences during the COVID-19 pandemic. The results showed that 221 of the participating mothers took 377 nonprescribed medications. The most commonly used medications were acetaminophen, gelofen compound, and cold medicines. The highest number of drugs (161) was taken in the first six months after delivery.
The most common problems and illnesses that led mothers to use nonprescribed medications during breastfeeding were migraines, pain, and respiratory problems. It was also shown that these mothers had accurate information about the side effects of the 212 nonprescribed medications on their infants. Furthermore, of the 377 medications, 279 could be used during breastfeeding. Correspondingly, most of the nonprescribed medications (74.0%) could be used safely when a mother breastfed, and discontinuing breastfeeding because of the medications was not necessary. The results showed there was a significant relationship between the mothers' education and their correct information about the side effects of nonprescribed medications. The mothers' education, fathers' jobs and income, and mothers' age had significant effects on the accuracy of the mothers' information about the secretion of the drug into breast milk. The mothers' jobs were significantly associated with the correct approach to routine breastfeeding. There are some similarities between the results reached in the above-mentioned studies and the ones obtained in the current study regarding the most common medications used and the indications for self-medication. But the most common differences in the results are related to the prevalence of selfmedication.
The contradictory results reported in the previous studies and the present one could be attributed to the participants' characteristics and the time of data collection. It seems that cultural and socioeconomic issues in different societies can influence decisions of people about self-medication [24]. It was reported that there was a relatively higher prevalence of self-medication among the Iranian people compared to that in other countries [25]. Also, financial issues are one of the main factors leading to self-medication in Iran (lower-middle income economy). As reported previously, the most important reason for self-medication in Iran was lack of health insurance [26]. Furthermore, the COVID-19 outbreak and the associated problems caused by this disease, especially people's concerns about being in crowded places such as doctors' offices or specialised clinics, made people self-medicate more frequently than before [27,28]. Increasing awareness of breastfeeding mothers about the risks of arbitrary use of drugs through educational programs is recommended [6,17].
The major limitation of this study was its restriction to one city in Iran. For more reliable assessments, it would be better to perform such studies in several cities of Iran.

Conclusion
The prevalence of self-medication by lactating women during the COVID-19 pandemic was very high. And a significant percentage of mothers did not have correct information about the adverse effect of arbitrary use of drugs on their babies.

Keypoints
The prevalence of self-medication by lactating women during the COVID-19 pandemic was very high. A significant percentage of mothers did not have correct information about the adverse effect of arbitrary use of drugs on their babies. There was a significant relationship between the mothers' education and their correct information about the side effects of nonprescribed medications on their infants. Also, the authors reported a positive relationship between the mothers' education and drug use during breastfeeding [20]. Also, Al-Sawalha et al. found that approximately 17% of the breastfeeding mothers used OTC medications and 7% used both OTC and prescribed medications. Most of the drugs that they took were painkillers and antibiotics. Half of the mothers were aware of the dangers of taking drugs for their babies. Two-thirds of the mothers read the drug information leaflets before taking their medications. Other sources of information about the medicines used by the mothers were health care providers, relatives, and the Internet. Furthermore, 49.1% of the mothers reported that they took the drugs during breastfeeding, but only 5.2% of them noticed side effects such as diarrhea or decreased activity in their infants [18]. The last finding was closely in line with the results of the present study.

ORCID IDs of the Authors
In a study, Mota et al. found that 19% of the mothers selfmedicated during breastfeeding. The medications used were nonsteroidal anti-inflammatory drugs, contraceptives, antibiotics, and antihypertensive drugs that were taken mostly for headaches and postoperative infections [21]. Chaves et al. showed that 52.4% of the mothers used self-medication during breastfeeding. The most commonly used drugs were analgesics, antipyretics, and nonsteroidal anti-inflammatory drugs. The results also showed that there was no relationship between any of the demographic variables and self-medication [8].
In another study, de Waard et al. showed that 75.9% of the mothers used OTC drugs, mostly painkillers and vitamins, during breastfeeding. Fifteen (11.3%) of the mothers used paracetamol plus codeine or morphine, which posed a (potential) risk to the baby; the rest of the drugs were safe or potentially safe [17]. Also, Jones and Brown showed that 53.6% of the women who breastfed their infants bought the drugs themselves. Most of the drugs used by them were painkillers and antibiotics [22]. Stultz et al. found that the drugs most commonly used by the breastfeeding women were multivitamins, nonsteroidal anti-inflammatory drugs, and acetaminophen [23].

Funding
None